Reversed shoulder arthroplasty (after proximal humerus fracture)
Conditions
Interventions
A Delta Xtend reversed shoulder prosthesis will be inserted in all patients.
All patients will receive a clinical and post clinical standardised
rehabilitation program.
Sponsors
Alysis Zorggroep
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * > 70 years of age * 4-part fracture confirmed by 2 orthopaedic surgeons on X-ray * Informed consent / patient information * Mentally alert and physically fit (ASA-group 1-3) for surgery and rehabilitation * The patient agrees to comply with postoperative clinical and radiographic evaluations and the required rehabilitation regime
Exclusion criteria
Exclusion criteria: * Pathological or complex fracture * Pathology of the contra lateral shoulder * Dementia * Active infection * Axillary nerve palsy * A deficient deltoid muscle * Abuse problems * Unable to understand the meaning of informed consent, the patient information, instructions in Dutch and follow the rehabilitation protocol * The subject has participated in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrolment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Constant Murley Score at 12 months between the intervention and historical control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Constant Murley score at 3 months. Visual analogue scale (VAS) for pain and impairment, range of motion (ROM), MecMesin myometer measurement of abduction force in Newton, and postoperative standing AP, axial and SOV radiographs at 3 and 12 months. Dutch simple shoulder test at 12 months. Perioperative complications, postoperative complications and adverse events will be counted for type (% of total events) at 12 months. | — |
Countries
Netherlands
Outcome results
None listed